Trovan Side Effects

Generic name: trovafloxacin

Note: This document provides detailed information about Trovan Side Effects associated with trovafloxacin. Some dosage forms listed on this page may not apply specifically to the brand name Trovan.

Applies to trovafloxacin: oral tablet.

Precautions

Alatrofloxacin and trovafloxacin (the active ingredient contained in Trovan) may cause liver problems, including liver failure, at any time during treatment in a small number of people who are treated with these medicines. Check with your doctor immediately if you notice that your urine has become dark or your skin or eyes are yellow in color or if you experience loss of appetite, nausea or vomiting, severe abdominal pain, or unusual tiredness or weakness. These may be possible signs or symptoms of a liver problem.

If you are taking aluminum- or magnesium-containing antacids, citric acid buffered with sodium citrate (e.g., Bicitra), iron supplements or vitamins, intravenous morphine, or sucralfate, do not take them at the same time that you take trovafloxacin tablets. It is best to take these medicines at least 2 hours before or 2 hours after taking trovafloxacin. These medicines may keep trovafloxacin tablets from working properly.

Some people who take alatrofloxacin or trovafloxacin may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn or skin rash, redness, itching, or discoloration. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Alatrofloxacin or trovafloxacin may cause some people to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Common side effects of Trovan

Some side effects of trovafloxacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of Trovan

Along with its needed effects, trovafloxacin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking trovafloxacin:

For healthcare professionals

Applies to trovafloxacin: intravenous solution, oral tablet.

General adverse events

In clinical trials, 90% of side effects were reported as mild or moderate. Therapy was discontinued due to side effects in 5% of patients, including dizziness (2.4%), nausea (1.9%), headache (1.1%), vomiting (1%).^[Ref]

Hepatic

Liver enzyme abnormalities and/or symptomatic hepatitis have occurred during short-term or long-term therapy. Liver enzyme abnormalities were primarily observed in patients receiving extended courses of therapy (longer than 21 days).^[Ref]

Hepatic side effects have included 5 deaths from liver toxicity and 4 patients requiring liver transplantation (one of which died) out of 140 cases of liver toxicity reported since the approval of trovafloxacin in February 1998. Symptomatic hepatitis (sometimes associated with peripheral eosinophilia, liver failure (including acute hepatic necrosis with eosinophilic infiltration) have been reported. Increased liver enzymes, abnormal hepatic function, bilirubinemia, discolored feces, and jaundice have been reported in less than 1% of patients. Increased ALT, AST, and alkaline phosphatase have been reported in 1% or more of patients.^[Ref]

Nervous system

A case of alatrofloxacin related seizure activity has been reported in the medical literature. The patient was given alatrofloxacin at the manufacturer's recommended dosage, concentration, and rate of infusion. Fifteen minutes into the infusion, the patient experienced generalized tonic movement of the upper torso which lasted 10 seconds. A rechallenge was performed, this time at a rate twice as slow as the initial dose. The patient experienced jaw and arm twitching, and alatrofloxacin was discontinued. The authors determined that the causal relationship between the drug and the event qualified as probable based on the Naranjo adverse event scoring method.

Dizziness or lightheadedness may last for several hours after a dose; however, is generally mild. It may resolve with continued therapy. 3.1% and 0.6% of patients over 65 years, respectively, reported dizziness and lightheadedness.^[Ref]

Nervous system side effects have included dizziness (2% to 11%), headache (1% to 5%), and lightheadedness (<1% to 4%). Abnormal coordination, abnormal gait, ataxia, cold clammy skin, confusion, convulsions, dry mouth, dyskinesia, dysphonia, encephalopathy, flushing, hyperkinesia, hypertonia, hypoesthesia, hypokinesia, increased saliva, increased sweating, involuntary muscle contractions, migraine, paresthesia, speech disorder, tongue paralysis, tremor, and vertigo have been reported in less than 1% of patients. Peripheral neuropathy has also been reported. Quinolone class antibiotics have been associated with possible exacerbation of myasthenia gravis.^[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea (4% to 8%), vomiting (1% to 3%), diarrhea (2%), and abdominal pain (1%). Other gastrointestinal effects including altered bowel habit, altered saliva, cheilitis, constipation, Clostridium difficile diarrhea, dyspepsia, dysphagia, eructation, flatulence, gastritis, gastroenteritis, gastrointestinal disorder, gingivitis,halitosis, increased appetite, loose stools, melena, pseudomembranous colitis, rectal disorder, stomatitis, tongue disorder, and tongue edema have been reported in less than 1% of treated patients. Pancreatitis has been reported during postmarketing experience. Quinolone class antibiotics have been associated with intestinal perforation.^[Ref]

Dermatologic

Dermatologic side effects have most commonly included pruritus and rash in <1% to 2% of patients. Pruritus ani, skin disorder, skin ulceration, angioedema, dermatitis, fungal dermatitis, photosensitivity, seborrhea, skin exfoliation, and urticaria have been reported in less than 1% of patients. Quinolone class antibiotics have been associated with erythema nodosum.^[Ref]

Hypersensitivity

Hypersensitivity reactions have included rash, Stevens-Johnson syndrome, photosensitivity, urticaria, exfoliative dermatitis, toxic epidermal necrolysis, angioedema, and anaphylaxis in less than 1% of patients. Phototoxicity was reported in less than 0.03% of study patients.^[Ref]

Genitourinary

Genitourinary side effects have included vaginitis (<1% to 2%), leukorrhea (<1%), and menstrual disorder (<1%) in females; balanoposthitis (<1%) in males. Dysuria, micturition frequency, and urinary incontinence have been reported in less than 1% of patients. Quinolone class antibiotics have been associated with albuminuria, candiduria, crystalluria, cylindruria, hematuria, and vaginal candidiasis.^[Ref]

Cardiovascular

Cardiovascular side effects have included arrhythmias, peripheral edema, chest pain, thrombophlebitis, hypotension, palpitations, hypertension, angina pectoris, postural hypotension, syncope, tachycardia, bradycardia, peripheral ischemia, edema, and face edema in less than 1% of treated patients.^[Ref]

Hematologic

Hematologic side effects have included anemia, granulocytopenia, hemorrhage, leukopenia, thrombocytopenia, thrombocythemia, and decreased prothrombin times in less than 1% of patients. Decreased hemoglobin and hematocrit, increased platelets, decreased and increased WBC, and eosinophilia have been reported in 1% or more of patients, although causality was not determined. Agranulocytosis, aplastic anemia, and pancytopenia have been reported during postmarketing experience. Quinolone class antibiotics have been associated with prothrombin time prolongation.^[Ref]

Metabolic

Metabolic side effects have included hyperglycemia, thirst, hyperglycemia, weight loss, and weight gain in less than 1% of patients. Decreased serum protein, albumin, sodium, and bicarbonate have been reported in 1% or more of patients, although causality was not determined. Quinolone class antibiotics have been associated with acidosis, symptomatic hypoglycemia, and elevations in serum triglycerides, serum cholesterol, blood glucose, and serum potassium.^[Ref]

Musculoskeletal

Musculoskeletal side effects including arthralgias, muscle cramps, myalgias, muscle weakness, skeletal pain, tendonitis, and arthropathy have been reported in less than 1% of patients. Quinolone class antibiotics have been associated with tendon rupture.^[Ref]

Respiratory

Respiratory side effects have included dyspnea, rhinitis, sinusitis, bronchospasm, asthma, increased cough, epistaxis, respiratory insufficiency, upper respiratory tract infection, respiratory disorder, hemoptysis, hypoxia, and stridor in less than 1% of patients. Quinolone class antibiotics have been associated with hiccough.^[Ref]

Ocular

Ocular side effects including conjunctivitis, photophobia, conjunctival hemorrhage, diplopia, eye pain, abnormal vision, scotoma, visual field defect, periorbital edema, and xerophthalmia have been reported in less than 1% of patients. Quinolone class antibiotics have been associated with nystagmus.^[Ref]

Psychiatric

Psychiatric side effects associated with the use of trovafloxacin (the active ingredient contained in Trovan) are rarely reported (less than 1% of patients) and have included anxiety, anorexia, agitation, nervousness, somnolence, insomnia, depression, amnesia, impaired concentration, depersonalization, abnormal dreaming, emotional lability, euphoria, hallucination, impotence, decreased male libido, paroniria, and abnormal thinking. Quinolone class antibiotics have been associated with manic reactions.^[Ref]

Local

Local intravenous site side effects have included inflammation, pain, and edema in up to 5% of patients.^[Ref]

Renal

Renal side effects have included increased BUN and creatinine in 1% or more of patients, and interstitial nephritis, acute renal failure, and abnormal renal function in less than 1% of patients. Quinolone class antibiotics have been associated with renal calculi.^[Ref]

Other

Other side effects have included fever, fatigue, pain, asthenia, moniliasis, hot flushes, back pain, chills, infection, malaise, sepsis, alcohol intolerance, taste perversion, hyperacusis, and tinnitus in less than 1% of patients.^[Ref]

See also:

Further information

Trovan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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